Supplier Quality Engineer

Responsibilities

• Perform incoming raw material inspections, approve material releases, and maintain purchasing specifications and process documentation.
• Partner closely with Production, Material Control, Engineering, and cross-functional teams to ensure supplier quality and supplier management requirements are met.
• Serve as a quality and regulatory resource for plant operations, project teams, and external stakeholders.
• Develop and maintain a strong understanding of manufacturing processes and products to investigate and resolve incoming material quality issues.
• Cook up and maintain effective supplier relationships while driving improvements in supplier quality performance.
• Cook and maintain supplier quality activities for both internal BD suppliers and external suppliers.
• Lead and support continuous improvement initiatives using established quality and operational excellence methodologies.
• Monitor, maintain, and communicate supplier quality performance metrics.
• Cook with Engineering to establish process parameters and acceptance criteria that ensure supplier process capability meets product and manufacturing requirements.
• Manage supplier quality activities for both internal BD suppliers and external suppliers.
• Support regulatory, customer, and internal audits, including FDA, NSAI, MDSAP, customer, and corporate audits.
• Ensure compliance with all company, local, state, and federal safety regulations, policies, and procedures.
• Uphold BD quality standards through consistent application of Quality Assurance principles, training, communication, and regulatory compliance requirements.
• Maintain accurate supplier documentation, including Approved Supplier Lists (ASL) and Supplier Files.
• Communicate specification changes to suppliers and coordinate Supplier Change Requests.
• Partner with Canaan-based internal and external suppliers to implement and maintain Supplier Quality Agreements.
• Support regulatory, customer, and internal audits, including FDA, NSAI, MDSAP, customer, and corporate audits.
• Ensure compliance with all company, local, state, and federal safety regulations, policies, and procedures.
• Monitor activities within assigned areas to support departmental budget objectives and provide input for budget planning.
• Promote and reinforce safety, environmental, quality, and compliance standards throughout daily operations.

Requirements

• B.S. or B.A. Degree in Science-related field, Quality Assurance, Engineering, Mathematics/Statistics or equivalent degree.
• 1 year of supplier quality experience.

Skills

• Working knowledge of Validations, IQ, OQ, PQ, and DOE's is desirable.
• A consistent record of supporting and driving continuous improvement activities in a production environment.